N/A
Completed N=378
Study of BD Pre-filled Flush Syringes in China
Effectiveness and Safety of Pre-filled Flush Syringe
Source: ClinicalTrials.gov NCT05763147 ↗
Enrolled (actual)
378
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: the Overall Performance for Flushing and / or Locking the Catheters. — 187; 185 participants
Summary
This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Overall Performance for Flushing and / or Locking the Catheters. |
187; 185 | — |
| SECONDARY Device Ease of Use |
187; 185 | — |
Eligibility Criteria
Inclusion Criteria
- 1. Age >or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion Criteria
- 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial.
- Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial.
- Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.
Data sourced from ClinicalTrials.gov (NCT05763147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.